Biosimilars & Generic Drugs Pre-Master’s Certificate
The Biosimilars & Generic Drugs Pre-Master’s Certificate in Temple’s School of Pharmacy gives graduate students the framework to understand how generic drugs are manufactured and regulated on the local, national and global levels. The certificate is part of Temple’s Regulatory Affairs and Quality Assurance (RAQA) graduate program, which is based in Fort Washington, Pennsylvania, approximately 20 miles from the Health Sciences Center in North Philadelphia. Courses take place on evenings and weekends to accomodate the schedules of working professionals.
The Biosimilars & Generic Drugs program focuses on the unique dynamics of generic drug distribution throughout the world. The curriculum delves into four key areas.
- Domestic and global regulations for generic products
- The global business environment
- Good distribution practices
- Manufacturing science
Starting with an overview of the drug development process, this certificate explores the global marketplace for generic drugs and biopharmaceuticals, building a strong foundation in generic regulatory issues. This includes exploring the Abbreviated New Drug Application process as well as analyzing both domestic and global distribution practices. The courses also immerse students in current trends and controversies facing the generic drug industry, including
- authorized generics,
- citizens’ petitions, and
- generic initiative for value and efficiency.
Students who complete the certificate requirements have the option to apply credits toward the Master of Science in Regulatory Affairs and Quality Assurance.
Classes & Curriculum
The certificate consists of five courses, which you can take on a part-time basis, with four years to complete the certificate. Required courses include
- Drug Development and
- Generic Drug Regulation: ANDAs.
Beyond the required courses, you may select electives like these.
- Analytical Chemistry in Pharmaceutical Laboratories
- Biologics/Biosimilars: A Regulatory Overview
- The Global Biopharmaceutical Industry (including Waxman Hatch)
- Global CMCs for Biologics
- Good Distribution Practices
- Global Pharmaceutical Excipient Regulation
- Pharmaceutical Manufacturing II
Related Graduate Degrees
- Global Clinical and Pharmacovigilance MS
- Pharmaceutical and Regulatory Sciences MS [ed. note: link to come]
- Pharmaceutical Sciences MS
- Pharmaceutical Sciences PhD
- Regulatory Affairs and Quality Assurance MS
Related Graduate Certificates
- Advanced Regulatory Affairs and Quality Assurance
- Basic Pharmaceutical Development
- Biopharmaceutical Manufacturing and Regulatory Affairs
- Clinical Trial Management
- Drug Development
- Food Regulatory Affairs and Quality Assurance
- Global Pharmacovigilance: Benefit-Risk Management
- Good Manufacturing Practicess for the 21st Century
- Medical Device
- Pharmaceutical Labeling, Advertising and Promotions
- Sterile Process Manufacturing